Heart Failure Solutions, Inc.
The PeriCut early feasibility study will evaluate the safety and feasibility of successfully performing a minimally invasive pericardiotomy in patients with heart failure with preserved ejection fraction using the PeriCut Catheter System.
The PeriCut EFS is a non-randomized, open label, multi-site study testing a new minimally invasive pericardiotomy device for the treatment of heart failure with preserved ejection fraction (HFpEF).
Inclusion Criteria * Age ≥ 30 years * Symptoms of severe dyspnea (NYHA Class III-IV) without evidence of a non-cardiac or ischemic explanation for dyspnea * Ejection fraction of ≥50%, determined on most recent imaging study within the preceding 2 years (730 days), with no change in clinical status, suggesting potential for deterioration in systolic function. * Documentation history of at least one of the following: Any previous hospitalization for HF (\>30 days prior to enrollment) with radiographic evidence of pulmonary congestion (pulmonary venous hypertension, vascular congestion, interst…
The PeriCut Catheter System will incise the pericardium to reduce filling pressures of the heart.
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